Blue Earth Diagnostics Receives Marketing Authorization for Axumin™ (Fluciclovine (18F)) for PET Imaging of Recurrent Prostate Cancer
Dr Jonathan Allis, CEO, Blue Earth Diagnostics said, “We are delighted by the European Commission’s marketing authorization for Axumin, which is a major milestone for Blue Earth Diagnostics and underlines our commitment to develop innovative molecular imaging agents that inform and guide treatment decisions for physicians and their patients. Axumin is our first approved product in Europe and we believe that it will benefit men with biochemically recurrent prostate cancer. We are now in discussions with potential manufacturing and distribution associates to make Axumin commercially available across Europe.”
Prostate cancer is the most common cancer in Europe for men, with around 343,000 new cases diagnosed each year. While most primary prostate cancer can be successfully treated, the disease recurs in up to one-third of patients. In some patients, recurrent disease is detectable only by a rise in PSA levels, but often the location of the recurrence cannot consistently be located by conventional imaging, limiting treatment guidance. Axumin was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer. It is labelled with the radioisotope (18F), enabling it to be visualized in the body with PET imaging.
Initially, Axumin will be commercially available in Europe in Norway, with roll-out to additional countries planned in 2018.
The Marketing Authorization Application for Axumin was submitted to the EMA in December 2015 and was approved on 22 May 2017.
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